Grant, Y.G.; (2011) Engineering the rational design and optimisation of lyophilization processes for biological materials. Doctoral thesis , UCL (University College London).

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Abstract

Lyophilization is a common method used for long term stability of pharmaceutical and biopharmaceutical products that are unstable in the liquid state for a substantial period of time. Currently, formulation and cycle development are often determined empirically. Although this approach is gradually changing as scientific publications reveal more about the nature of protein stability, nevertheless the lack of material during early stage development prevents large screening investigations to identify optimum formulations. The use of high throughput methods coupled with factorially designed experiments enables a far more efficient and wider screening and optimisation of viable formulations for development. This thesis explores the use of micro titre plates for formulation development with emphasis on formulations for lyophilization. This is coupled with design of experiment methods to provide a powerful engineering tool for the formulation scientist. While much has been done to model freeze drying cycles and optimize cycle parameters, current models are generic and require system specific data which can be hard to collect. By applying design of experiment principles, a system specific model was developed to allow the optimisation of cycle development to identify key parameters and produce a product that would meet critical quality attributes. Such a platform would lend itself well to quality by design and its application in lyophilization development.

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